Top

Tag: biotechnology


FDA, News, Regulations

FDA Action Alert: Blueprint, Liquidia, Revance, Rhythm and Merck

November 23, 2020

Via: BioSpace

The U.S. Food and Drug Administration (FDA) has a busy end of November planned, with numerous PDUFA dates to address. Here’s a look at the upcoming week. Blueprint Medicines’ Pralsetinib for Non-Small Cell Lung Cancer Blueprint Medicines had a target […]


Industry, Vaccines

AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19

November 23, 2020

Via: World Pharma News

Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported […]


Industry, Vaccines

Pfizer and BioNTech request emergency authorization from FDA for Covid vaccine

November 20, 2020

Via: CNBC

Pfizer and BioNTech on Friday applied for an emergency use authorization from the Food and Drug Administration for their coronavirus vaccine. If Pfizer’s application is approved, the vaccine will likely be limited and rolled out in phases, with health-care workers, […]


Cell and Gene Therapy, Industry

New findings speed progress towards affordable gene therapy

November 20, 2020

Via: ScienceDaily

Researchers used metal-organic frameworks (MOFs) enhanced with a green tea phytochemical coating to target human prostate cancer cells for the first time. The new method for deploying the genetic snipping tool directly into target cells is a big step towards […]


Industry, Vaccines

Hospitals scramble to get ready for coronavirus vaccines

November 19, 2020

Via: Biopharma Dive

Hospitals across the country are ramping up their efforts to figure out how to store, track and administer coronavirus vaccine doses as confidence grows that an effective vaccine could soon become available. Hospitals will play a key role once a […]


Cell and Gene Therapy, Industry, News

Catalent Appoints Open Innovation, Biologics, Cell and Gene Therapy VP

November 19, 2020

Via: Contract Pharma

Catalent has appointed Behzad Mahdavi, Ph.D., MBA, as Vice President of Open Innovation, Biologics, Cell and Gene Therapy. In this new role, Dr. Mahdavi will join a team of experts in Catalent’s Science and Technology Group that works with customers […]


FDA, Regulations

FDA said to plan early December advisory meetings to discuss Covid-19 vaccines ahead of potential authorization

November 18, 2020

Via: CNBC

The Food and Drug Administration has asked a group of advisors to set aside three days in early December for potential meetings to discuss Covid-19 vaccines — a key step in the agency’s authorization process, according to two people familiar […]


Industry, News, Vaccines

Immune-Boosting Components Double the Effectiveness of Melanoma Vaccine Candidate in Phase II Trial

November 18, 2020

Via: Genetic Engineering and Biotechnology News

A vaccine created to prevent the recurrence of the deadly skin cancer melanoma is about twice as effective when patients also receive two components that boost the number and effectiveness of immune system dendritic cells (DCs), according to the results […]


Clinical Trials, Research and Development

New Technique Developed to Study Cell Types in Parkinson’s Disease

November 17, 2020

Via: Genetic Engineering and Biotechnology News

Parkinson’s disease (PD) is a progressive disorder that affects nerve cells in the brain responsible for body movement. When dopamine-producing neurons die, symptoms such as tremor, slowness, stiffness, and balance problems occur. Researchers at Carnegie Mellon University (CMU) have developed […]


Cell and Gene Therapy, Industry

Boosting Capabilities in Gene and Cell Therapy Bioprocessing

November 17, 2020

Via: Genetic Engineering and Biotechnology News

A new company has been founded to supply software for managing cell & gene therapy manufacturing. Autolomous, founded in February 2019, has already secured four different clients whom they hope to assist with digitizing and streamlining their workflows. “There’s a […]


Industry, Vaccines

Moderna COVID-19 Vaccine 94.5% Effective in Early Phase III Data

November 16, 2020

Via: Genetic Engineering and Biotechnology News

Moderna said today that its COVID-19 vaccine candidate mRNA-1273 passed its most important test, the 30,000+ patient Phase III COVE trial (NCT04470427), by showing itself to be 94.5% effective in preventing COVID-19—an outcome hailed by CEO Stéphane Bancel as a […]


Cell and Gene Therapy, Industry

New Therapeutic Target Identified for Breast Cancer Treatment

November 16, 2020

Via: Genetic Engineering and Biotechnology News

Lemur tyrosine kinase 3 (LMTK3) is associated with cell proliferation and endocrine resistance in breast cancer. Now, a team of researchers from the University of Sussex has completed a five-year study that provides evidence for a potential new target for […]